United States
`Environmental Protection
` Agency
`
`Prevention, Pesticides
`and Toxic Substances
` (7508C)
`
`EPA 738-R-01-013
`September 2001
`
`Reregistration
`Eligibility Decision for
`Acephate
`
`
`
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`TIDE 1012
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` thEDUOD
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`m>HIUEddamm:
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`United States
`Environmental Protection
`Agency
`
`Prevention, Pesticides
`and Toxic Substances
`(7508C)
`
`EPA 738-F-01-013
`September 2001
`
`Acephate Facts
`
`
`EPA has assessed the risks of acephate and reached an Interim Reregistration Eligibility
`Decision (IRED) for this organophosphate (OP) pesticide. Provided that risk mitigation measures are
`adopted, acephate fits into its own “risk cup”-- its individual, aggregate risks are within acceptable
`levels. Acephate also is eligible for reregistration, pending a full reassessment of the cumulative risk
`from all OPs.
`
`Acephate residues in food and drinking water
`do not pose risk concerns, and by reducing exposure
`in homes and through residential lawns, acephate fits
`into its own “risk cup.” EPA made this
`determination after the registrants agreed to drop
`indoor residential uses and certain turf uses. With
`other mitigation measures, acephate’s worker and
`ecological risks also will be below levels of concern
`for reregistration.
`
`EPA’s next step under the Food Quality
`Protection Act (FQPA) is to consider risks from
`cumulative exposure to all the OP pesticides, which
`share a common mechanism of toxicity. The interim
`decision on acephate cannot be considered final until
`the cumulative risk has been considered. Further
`risk mitigation may be warranted at that time.
`
`EPA is reviewing the OP pesticides to
`determine whether they meet current health and
`safety standards. Older OPs need decisions about
`their eligibility for reregistration under FIFRA. OPs
`with residues in food, drinking water, and other non-
`occupational exposures also must be reassessed to
`make sure they meet the new FQPA safety standard.
`
`The OP Pilot Public Participation Process
`
`The organophosphates are a group of
`related pesticides that affect the functioning of the
`nervous system. They are among EPA’s highest
`priority for review under the Food Quality
`Protection Act.
`EPA is encouraging the public to
`participate in the review of the OP pesticides.
`Through a six-phased pilot public participation
`process, the Agency is releasing for review and
`comment its preliminary and revised scientific risk
`assessments for individual OPs. (Please contact
`the OP Docket, telephone 703-305-5805, or see
`EPA’s web site, www.epa.gov/pesticides/op .)
`EPA is exchanging information with
`stakeholders and the public about the OPs, their
`uses, and risks through Technical Briefings,
`stakeholder meetings, and other fora. USDA is
`coordinating input from growers and other OP
`pesticide users.
`Based on current information from
`interested stakeholders and the public, EPA is
`making interim risk management decisions for
`individual OP pesticides, and will make final
`decisions after the cumulative risk from all OPs
`has been considered.
`
`The acephate interim decision was made through the OP pilot public participation process, a
`process that increases transparency and maximizes stakeholder involvement in EPA’s development of
`risk assessments and risk management decisions. EPA worked extensively with affected parties to
`reach the decisions presented in this interim decision document that concludes the OP pilot process
`for acephate.
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`Uses
`
`•
`
`•
`
`Acephate is an organophosphate insecticide currently registered for use on a variety of field,
`fruit, and vegetable crops (e.g., cotton, tobacco, cranberries, mint); in food handling
`establishments; on ornamental plants both in greenhouses and outdoors (e.g., nonbearing fruit
`trees, Christmas trees, and cut flowers); and in and around the home.
`
`Annual domestic use is approximately 4 to 5 million pounds of active ingredient per year.
`
`Health Effects
`
`•
`
`Acephate can cause cholinesterase inhibition in humans; that is, it can overstimulate the
`nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
`accidents or major spills), respiratory paralysis and death.
`
`Risks
`
`•
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`•
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`•
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`•
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`Dietary exposures to acephate from eating food crops treated with acephate are below the
`level of concern for the entire U.S. population, including infants and children. Drinking water
`is not a significant source of acephate exposure. However, people in the U.S. may be exposed
`to amounts of the acephate degradate methamidophos through food and drinking water as a
`result of acephate use. This exposure will be more fully addressed in the methamidophos
`IRED.
`
`EPA found risks are of concern for homeowners and children entering homes and lawn areas
`treated with acephate (excluding golf courses and spot or mound treatments for ant control).
`
`For agricultural and turf/Pest Control Operator (PCO) uses of acephate, several
`mixer/loader/applicator risk scenarios currently exceed the Agency’s level of concern. In
`addition, there are postapplication risks from the use of acephate in cut flowers.
`
`Ecological risks are also of concern to the Agency. Acephate and its degradate
`methamidophos are highly toxic to honey bees and beneficial predatory insects on an acute
`contact basis. Acute and chronic risks to birds and chronic risk to mammals are also high.
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`Risk Mitigation
`
`Dietary Risk
`
`No mitigation is necessary at this time for any dietary exposure to acephate. The acute and
`chronic dietary risks from acephate do not exceed the Agency’s level of concern.
`
`However, the Agency reserves the right to require further acephate mitigation to address risks
`from methamidophos residues resulting from acephate uses. Any additional mitigation measures will
`be addressed when the methamidophos interim RED is completed.
`
`Occupational Risk
`
`In order to mitigate occupational risks, the following risk mitigation measures are necessary:
`
`Formulate all soluble powder formulations into water soluble bags, except for soluble
`powders sold for fire ant, harvester ant, or hopper box seed treatment uses.
`Limit the 1 pound active ingredient per acre (lb ai/A) cotton aerial application rate to cotton
`grown in California and Arizona; reduce the maximum aerial application rate for cotton to
`0.75 ai/A for all other areas of the United States.
`Delete aerial application to turf.
`Require enclosed cockpits and mechanical flagging for all aerial applications.
`Reduce maximum sod farm and golf course turf application rates (non-granular formulations)
`to 3 lb ai/A and 4 lb ai/A, respectively.
`Reduce maximum application rates for greenhouse floral and foliage plant crops, and outdoor
`floral and ground covers to 1 lb ai per 100 gallons water (not to exceed 0.75 lb ai/A for cut
`flowers and 1.0 lb ai/A for other ornamentals).
`Delete the application of acephate by low pressure handwand to treat trees, shrubs, and
`outdoor flora; for the control of wasps; and for perimeter treatment by PCOs.
`Delete the use of granular formulations to be applied by belly grinder, shaker can, or by hand
`to trees, shrubs, and 12" pots.
`Add personal protective equipment to end use product labels for workers who mix and load,
`and/or apply acephate.
`
`•
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`•
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`•
`•
`•
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`•
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`•
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`•
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`•
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`Residential Risk
`
`In order to mitigate residential postapplication risk, the following risk mitigation measures are
`necessary:
`
`•
`•
`
`•
`
`Delete residential indoor uses.
`Delete all turfgrass uses (except golf course, sod farm, and spot or mound treatment for ant
`control).
`Establish a 3 day pre-harvest interval (PHI) for the harvesting of sod.
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`Ecological Risk
`
`The Agency has determined that the following mitigation measures are needed to address
`ecological risk concerns:
`
`•
`
`•
`•
`
`Establish minimum spray intervals for all agricultural crops of 3 days for application rates up
`to 0.5 lb ai/A and of 7 days for application rates greater than 0.5 lb ai/A.
`Require labeling to protect honeybees.
`Require labeling to reduce the potential for spray drift.
`
`In addition, the measures to reduce occupational and residential risk will also reduce
`environmental loading and the potential impact to non-target organisms.
`
`Next Steps
`
`•
`
`•
`
`•
`
`Numerous opportunities for public comment were offered as this decision was being
`developed. The acephate IRED therefore is issued in final (see
`www.epa.gov/pesticides/reregistration/status.htm or www.epa.gov/pesticides/op ), without a
`formal public comment period. The docket remains open, however, and any comments
`submitted in the future will be placed in this public docket.
`
`In addition, further mitigation of acephate uses may be necessary to reduce risks from
`methamidophos residues that result from acephate applications. Once the methamidophos
`IRED is complete, the Agency will determine whether the methamidophos exposure resulting
`from acephate use poses risk concerns. Any potential further mitigation will be discussed at
`the time the methamidophos interim RED is released.
`
`When the cumulative risk assessment for all organophosphate pesticides is completed, EPA
`will issue its final tolerance reassessment decision for acephate and may request further risk
`mitigation measures. The Agency will revoke 3 tolerances and lower 4 tolerances for
`acephate now. Reassessment of 14 tolerances will be made once additional residue data on
`cotton gin byproducts have been reviewed. For all OPs, raising and/or establishing tolerances
`will be considered once a cumulative assessment is completed.
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`UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
`WASHINGTON, D.C. 20460
`
`
`
`CERTIFIED MAIL
`
`Dear Registrants:
`
`OFFICE OF
`PREVENTION, PESTICIDES
`AND TOXIC SUBSTANCES
`
`This is to inform you that the Environmental Protection Agency (hereafter referred to as
`EPA or the Agency) has completed its review of the available data and public comments
`received related to the preliminary and revised risk assessments for the organophosphate
`pesticide acephate. The public comment period on the revised risk assessment phase of the
`reregistration process is closed. Based on comments received during the public comment period
`and additional data received from the registrants, the Agency revised the human health and
`environmental effects risk assessments and made them available to the public on February 22,
`2000. Additionally, the Agency held a Technical Briefing on February 2, 2000, where the
`results of the revised human health and environmental effects risk assessments were presented to
`the general public. This Technical Briefing concluded Phase 4 of the OP Public Participation
`Pilot Process developed by the Tolerance Reassessment Advisory Committee (TRAC), and
`initiated Phase 5 of that process. During Phase 5, all interested parties were invited to participate
`and provide comments and suggestions on ways the Agency might mitigate the estimated risks
`presented in the revised risk assessments. This public participation and comment period
`commenced on February 22, 2000, and closed on April 24, 2000.
`
`Based on its review, EPA has identified risk mitigation measures that the Agency believes
`are necessary to address the human health and environmental risks associated with the current
`use of acephate. The EPA is now publishing its interim decision on the reregistration eligibility
`of and risk management decision for the current uses of acephate and associated human health
`and environmental risks. The reregistration eligibility and tolerance reassessment decisions for
`acephate will be finalized once the cumulative assessment for all of the organophosphate
`pesticides is complete. The enclosed “Interim Reregistration Eligibility Decision for Acephate”
`was approved on September 28, 2001, and contains the Agency’s decision on the individual
`chemical acephate.
`
`A Notice of Availability for this Interim Reregistration Eligibility Decision (interim RED)
`is being published in the Federal Register. To obtain a copy of the interim RED document,
`please contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200
`Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic
`copies of the interim RED and all supporting documents are available on the Internet. See
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`http:www.epa.gov/pesticides/op.
`
`The interim RED is based on the updated technical information found in the acephate
`public docket. The docket includes background information and comments on the Agency’s
`preliminary risk assessments; the Agency’s February 3, 2000, revised risk assessment for
`acephate; addenda to the occupational and residential risk assessments (September 15, 2000 and
`February 13, 2001); a revised surface water assessment (March 8, 2000); and a document
`summarizing the Agency’s Response to Comments. The Response to Comments document
`addresses corrections to the preliminary risk assessments submitted by chemical registrants and
`responds to comments submitted by the general public and stakeholders during the comment
`period on the risk assessment. The docket also includes comments on the revised risk
`assessment, and any risk mitigation proposals submitted during Phase 5. For acephate, a
`proposal was submitted by Valent U.S.A. Corporation (Valent), a technical registrant. All other
`technical registrants have agreed to the mitigation measures proposed. Comments on mitigation
`or mitigation suggestions were submitted by growers, agricultural extension agents,
`environmental organizations, university scientists, and various other organizations.
`
`This document and the process used to develop it are the result of a pilot process to
`facilitate greater public involvement and participation in the reregistration and/or tolerance
`reassessment decisions for these pesticides. As part of the Agency’s effort to involve the public
`in the implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is
`undertaking a special effort to maintain open public dockets on the organophosphate pesticides
`and to engage the public in the reregistration and tolerance reassessment processes for these
`chemicals. This open process follows the guidance developed by TRAC, a large multi-
`stakeholder advisory body that advised the Agency on implementing the new provisions of the
`FQPA. The reregistration and tolerance reassessment reviews for the organophosphate
`pesticides are following this new process.
`
`Please note that the acephate risk assessment and the attached interim RED concern only
`this particular organophosphate. This interim RED presents the Agency’s conclusions on the
`dietary and residential risks posed by exposure to acephate alone. The Agency has also
`concluded its assessment of the ecological and worker risks associated with the use of acephate.
`Because the FQPA directs the Agency to consider available information on the basis of
`cumulative risk from substances sharing a common mechanism of toxicity, such as the toxicity
`expressed by the organophosphates through a common biochemical interaction with
`cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire
`organophosphate class of chemicals after considering the risks for the individual
`organophosphates. The Agency is working towards completion of a methodology to assess
`cumulative risk and the individual risk assessments for each organophosphate are likely to be
`necessary elements of any cumulative assessment. The Agency has decided to move forward
`with individual assessments and to identify mitigation measures necessary to address those
`human health and environmental risks associated with the current uses of acephate. The Agency
`will issue the final tolerance reassessment decision for acephate and finalize decisions on
`reregistration eligibility once the cumulative risks for all of the organophophates are considered.
`This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
`outline(s) further data requirements for this chemical. Note that a complete DCI, with all
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`pertinent instructions, is being sent to registrants under a separate cover. Additionally, for
`product-specific DCIs, the first set of required responses is due 90 days from the receipt of the
`DCI letter. The second set of required responses is due eight months from the date of the DCI.
`
`
`Notwithstanding the consideration of the cumulative risk from the OPs, the Agency has
`determined that acephate is eligible for reregistration provided that all the conditions identified
`in this document are satisfied, including implementation of the risk mitigation measures outlined
`in Section IV of the document. The Agency believes that certain current uses of acephate pose
`unreasonable adverse effects to human health and the environment, and that such effects can be
`mitigated with the risk mitigation measures identified in this interim RED. Accordingly, the
`Agency recommends that registrants implement these risk mitigation measures immediately.
`Section V of this interim RED describes labeling amendments for end-use products and data
`requirements necessary to implement these mitigation measures. Instructions for registrants on
`submitting revised labeling and the time frame established to do so can be found in Section VI of
`this document.
`
`Should a registrant fail to implement any of the risk mitigation measures outlined in this
`document, the Agency will resume appropriate action to address concerns about the risks posed
`by acephate. Where the Agency has identified any unreasonable adverse effect to human health
`or the environment, the Agency may at any time initiate regulatory action to address this
`concern. At that time, any affected person(s) may challenge the Agency’s action.
`
`If you have questions on this document or the label changes necessary for reregistration,
`please contact the Chemical Review Manager, Kimberly Nesci at (703) 308-8059. For questions
`about product reregistration and/or the Product DCI that accompanies this document, please
`contact Bonnie Adler at (703) 308-8523.
`
`Sincerely,
`
`Lois A. Rossi, Director
`Special Review and
`Reregistration Division
`
`Attachment
`
`9
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`

`Interim Reregistration Eligibility Decision
`for
`Acephate
`
`Case No. 0042
`
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`TABLE OF CONTENTS
`
`ACEPHATE TEAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
`
`Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
`
`I.
`
`Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
`
`II. Chemical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`A.
`Regulatory History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`B.
`Chemical Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`C.
`Use Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`D.
`Estimated Usage of Pesticide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
`
`2.
`
`3.
`
`III. Summary of Acephate Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
`A. Human Health Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`1.
`Dietary Risk from Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`a.
`Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`b.
`FQPA Safety Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`c.
` Population Adjusted Dose (PAD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
`d.
`Exposure Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
`e.
`Food Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
`Dietary Risk from Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
`a.
`Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
`b.
`Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
`c.
`Drinking Water Levels of Comparison (DWLOCs) . . . . . . . . . . . . 11
`Residential Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`a.
`Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`b.
`Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
`c.
`Residential Handler Risk Summary . . . . . . . . . . . . . . . . . . . . . . . . . 14
`1)
`Residential Applicator Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
`2)
`Postapplication Residential Risk . . . . . . . . . . . . . . . . . . . . . . . 16
`Aggregate Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
`Occupational Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
`a.
`Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
`b.
`Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
`c.
`Occupational & Residential Handler Risk Summary . . . . . . . . . . . 20
`1)
`Agricultural Handler Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
`2)
`Pest Control Operator and Turf Use Risk . . . . . . . . . . . . . . . 27
`3)
`Postapplication Occupational Risk . . . . . . . . . . . . . . . . . . . . . 29
`Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
`1.
`Environmental Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`a.
`Degradation and Mobility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`b.
`Field Dissipation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`
`4.
`5.
`
`B.
`
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`c.
`
`Bioaccumulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`c.
`Risk to Terrestrial Organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`a.
`Birds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`1)
`Acute and Subacute Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . 31
`2)
`Chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
`3)
`Avian Exposure and Risk Characterization . . . . . . . . . . . . . . 32
`b. Mammals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
`1)
`Acute and Chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
`2) Mammalian Exposure and Risk Characterization . . . . . . . . 33
`Insects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
`1)
`Acute Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
`2)
`Non-Target Insect Exposure and Risk Characterization . . . 34
`Risk to Aquatic Organisms and Ecosystems . . . . . . . . . . . . . . . . . . . . . . . 34
`a.
`Freshwater Organism Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
`1)
`Fish Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
`2)
`Freshwater Amphibian Toxicity . . . . . . . . . . . . . . . . . . . . . . . 34
`3)
`Freshwater Invertebrate Toxicity . . . . . . . . . . . . . . . . . . . . . . 35
`Estuarine and Marine Organism Toxicity . . . . . . . . . . . . . . . . . . . . 35
`1)
`Estuarine and Marine Fish Toxicity . . . . . . . . . . . . . . . . . . . . 35
`2)
`Estuarine and Marine Invertebrate Toxicity . . . . . . . . . . . . . 35
`Aquatic Exposure and Risk Characterization . . . . . . . . . . . . . . . . . 35
`c.
`Risk to Endangered Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
`
`b.
`
`2.
`
`3.
`
`4.
`
`IV.
`
`D.
`
`Interim Risk Management and Reregistration Decision . . . . . . . . . . . . . . . . . . . . . . . 37
`A.
`Determination of Interim Reregistration Eligibility . . . . . . . . . . . . . . . . . . . . . . 37
`B.
`Summary of Phase 5 Comments and Responses . . . . . . . . . . . . . . . . . . . . . . . . . 40
`C.
`FQPA Assessment
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
`1.
`“Risk Cup” Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
`2.
`Tolerance Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
`3.
`Codex Harmonization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
`4.
`Analytical Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
`5.
`Endocrine Disruptor Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
`Regulatory Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
`1.
`Human Health Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
`a.
`Dietary Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
`b.
`Residential Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
`1)
`Residential Handler Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
`2)
`Residential Postapplication Risk . . . . . . . . . . . . . . . . . . . . . . . 47
`Aggregate Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
`c.
`Occupational Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
`d.
`Environmental Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
`Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
`a.
`Endangered Species Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
`b.
`Spray Drift Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
`
`2.
`3.
`
`12
`
`

`

`V. What Registrants Need to Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
`A. Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
`1.
`Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
`2.
`Labeling for Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . 60
`End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
`1.
`Additional Product-Specific Data Requirements . . . . . . . . . . . . . . . . . . . 60
`2.
`Labeling for End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
`Existing Stocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
`Labeling Changes Summary Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
`
`C.
`D.
`
`B.
`
`VI. Related Documents and How to Access Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
`
`VII. Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
`APPENDIX A: Use Patterns Eligible for Reregistration . . . . . . . . . . . . . . . . . . . . . . 89
`APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of
`Acephate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
`APPENDIX C: Technical Support Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
`APPENDIX D: Citations Considered to be Part of the Database Supporting the
`Acephate Interim Reregistration Eligibility Decision (Bibliography)
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
`APPENDIX E. Generic Data Call-In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
`APPENDIX F. Product Specific Data Call-In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
`APPENDIX G. EPA’S Batching of Acephate Product for Meeting Acute Toxicity
`Data Requirements for Reregistration . . . . . . . . . . . . . . . . . . . . . . 165
`APPENDIX H. List of Registrants Sent This Data Call-In . . . . . . . . . . . . . . . . . . . 169
`APPENDIX I.
`List of Available Related Documents and Electronically Available
`Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
`
`13
`
`

`

`ACEPHATE TEAM
`
`Office of Pesticide Programs:
`
`Health Effects Risk Assessment
`Jeffrey L. Dawson
`Felecia A. Fort
`Susan Hanley
`Catherine Bodurow Joseph
`Nancy McCarroll
`
`Environmental Fate Risk Assessment
`
`Michael Davy
`Stephanie Syslo
`
`Use and Usage Analysis
`
`William Gross
`Alan Halvorson
`
`Registration Support
`
`Marilyn Mautz
`
`Risk Management
`
`Monica Alvarez
`Daniel Helfgott
`Kimberly Nesci Lowe
`
`Reregistration Branch I
`Reregistration Branch I
`Reregistration Branch I
`Reregistration Branch I
`Toxicology Branch
`
`Environmental Risk Branch II
`Environmental Risk Branch II
`
`Herbicide & Insecticide Branch
`Economic Analysis Branch
`
`Insecticide & Rodenticide Branch
`
`Special Review Branch
`Special Review Branch
`Special Review Branch
`
`i
`
`14
`
`

`

`GLOSSARY OF TERMS AND ABBREVIATIONS
`
`AE
`a.i.
`AGDCI
`ai
`aPAD
`AR
`ARC
`BCF
`CAS
`CI
`CNS
`cPAD
`CSF
`CFR
`CSFII
`DCI
`DEEM
`DFR
`DRES
`DWEL
`
`DWLOC
`EC
`EEC
`
`EP
`EPA
`FAO
`FDA
`FIFRA
`FFDCA
`FQPA
`FOB
`G
`GENEEC
`GLC
`GLN
`GM
`GRAS
`HA
`
`HAFT
`HDT
`IR
`LC50
`
`LD50
`
`Acid Equivalent
`Active Ingredient
`Agricultural Data Call-In
`Active Ingredient
`Acute Population Adjusted Dose
`Anticipated Residue
`Anticipated Residue Contribution
`Bioconcentration Factor
`Chemical Abstracts Service
`Cation
`Central Nervous System
`Chronic Population Adjusted Dose
`Confidential Statement of Formula
`Code of Federal Regulations
`USDA Continuing Surveys for Food Intake by Individuals
`Data Call-In
`Dietary Exposure Evaluation Model
`Dislodgeable Foliar Residue
`Dietary Risk Evaluation System
`Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.,
`drinking water) lifetime exposure at which adverse, noncarcinogenic health effects are not
`anticipated to occur.
`Drinking Water Level of Comparison.
`Emulsifiable Concentrate Formulation
`Estimated Environmental Concentration. The estimated pesticide concentration in an
`environment, such as a terrestrial ecosystem.
`End-Use Product
`U.S. Environmental Protection Agency
`Food and Agriculture Organization
`Food and Drug Administration
`Federal Insecticide, Fungicide, and Rodenticide Act
`Federal Food, Drug, and Cosmetic Act
`Food Quality Protection Act
`Functional Observation Battery
`Granular Formulation
`Tier I Surface Water Computer Model
`Gas Liquid Chromatography
`Guideline Number
`Geometric Mean
`Generally Recognized as Safe as Designated by FDA
`Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
`organizations when emergency spills or contamination situations occur.
`Highest Average Field Trial
`Highest Dose Tested
`Index Reservoir
`Median Lethal Concentration. A statistically derived concentration of a substance that can be
`expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
`per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.
`Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
`50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
`expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
`
`ii
`
`15
`
`

`

`LEL
`LOC
`LOD
`LOAEL
`MATC
`MCLG
`
`mg/kg/day
`mg/L
`MOE
`MP
`MPI
`MRID
`NA
`N/A
`NAWQA
`NOEC
`NOEL
`NOAEL
`NPDES
`NR
`OP
`OPP
`OPPTS
`Pa
`PAD
`PADI
`PAG
`PAM
`PCA
`PCO
`PDP
`PHED
`PHI
`ppb
`PPE
`ppm
`PRN
`PRZM/
`EXAMS
`Q1*
`RAC
`RBC
`RED
`REI
`RfD
`RQ
`RS
`RUP
`SAP
`SCI-GROW
`SF
`SLC
`
`Lowest Effect Level
`Level of Concern
`Limit of Detection
`Lowest Observed Adverse Effect Level
`Maximum Acceptable Toxicant Concentration
`Maximum Contaminant Level Goal. The MCLG is used by the Agency to regulate contaminants
`in drinking water under the Safe Drinking Water Act.
`Milligram Per Kilogr